Magellan Healthcare Original Date: November 2, 2015 ... · Chiropractic Biophysics (CBP, Clinical...

Magellan Healthcare

Clinical guidelines

EXPERIMENTAL, UNPROVEN, OR

INVESTIGATIONAL SERVICES

Original Date: November 2, 2015

of 13

Physical Medicine – Clinical Decision Making Last Review Date: June 2017

Guideline Number: NIA_CG_601 Last Revised Date: June 2017

Responsible Department:

Clinical Operations

Implementation Date: January 2018

1—Experimental_Unproven_Investigational Services 2018 Proprietary

Policy Statement

This policy will be used to provide a listing of procedures considered experimental,

investigational by any physical medicine practitioner. Services listed in the policy are not

eligible for reimbursement.

Initial Clinical Reviewers (ICRs) and Physician Clinical Reviewers (PCRs) must be able to

apply criteria based on individual needs and based on an assessment of the local delivery

system.

Purpose

To provide a listing of procedures considered experimental, investigational or unproven

services by any physical medicine practitioner, including chiropractors, physical therapists,

occupational therapists, and speech language pathologists.

Scope

Clinical Management, Coding, Customer Service, Claims and Contracting.

Coverage

Coverage is subject to the terms of an enrollee’s benefit plan. To the extent there is any

inconsistency between this medical policy and the terms of an enrollee’s benefit plan, the

terms of the enrollee’s benefit plan documents will always control. Investigational services

are not covered under enrollee’s health plan.

Definition

A service is considered experimental/investigation if any of the following criteria is met:

1. The services, procedures or supplies requiring Federal or other Governmental body

approval, such as drugs and devices, do not have unrestricted market approval from the

Food and Drug Administration (FDA) or final approval from any other governmental

regulatory body for use in treatment of a specified condition. Any approval that is

granted as an interim step in the regulatory process is not a substitute for final or

unrestricted market approval.

2. There is insufficient or inconclusive medical and scientific evidence to evaluate the

therapeutic value of the service, procedure or supply.


3. There is inconclusive medical and scientific evidence in peer-reviewed medical

literature that the service, procedure or supply has a beneficial effect on health

outcomes.

4. The service, procedure or supply under consideration is not as beneficial as any

established alternatives.

5. There is insufficient information or inconclusive scientific evidence that, when used in

a non-investigational setting, the service, procedure or supply has a beneficial effect on

health outcomes or is as beneficial as any established alternatives.

Experimental and investigational services include the use of a service, procedure or supply

that is not recognized as standard clinical care for the condition, disease, illness or injury

being treated. A service, procedure or supply includes, but is not limited to the diagnostic

service, treatment, facility, equipment, or device. Magellan Healthcare and their client

health plan will determine whether a service, procedure, or supply is considered

experimental and investigational.

The following is a partial listing of experimental and investigational services:

Advanced BioStructural Correction (ABC)

Alphabiotics

Applied Kinesiology or any of its derivations

Applied Spinal Biomechanical Engineering

BioEnergetic Synchronization Technique (B.E.S.T)

Chiropractic Biophysics (CBP, Clinical Biomechanics of Posture, CBP Mirror Image

Technique)

Coccygeal Meningeal Stress Fixation

Cold Laser Therapy

Computerized muscle testing or analysis

Craniosacral Therapy (CST)

Directional Non-force Technique

Spinal Diagnostic Ultrasound

Hako-Med electrotherapy (horizontal electrotherapy)

Hippotherapy

Impulse adjusting instrument

Intersegmental traction and Autotraction

Kinesio taping (Elastic Therapeutic Taping)

Live Cell Analysis or hair analysis

Manipulation under Anesthesia (MUA)

Moire Contourographic Analysis

Nambudripad’s Allergy Elimination Technique (NAET)/ other Allergy Testing

National Upper Cervical Chiropractic Association (NUCCA technique)/Grostic

technique

Network Chiropractic, NeuroEmotional Technique (NET)

Neurocalometer, Nervoscope, Nerve Conduction Velocity, Surface EMG, Paraspinal

Electromyography, Spinoscopy or other nerve conduction testing for non-specific

neck and back pain


Neural Organizational Technique, Contact Reflex Analysis (CRA), Whole System

Scan

Nimmo Receptor-Tonus method

Pettibon and wobble chair/board treatment

Preventive Care, Maintenance Care, Corrective Care

Pro-Adjuster

Sacro Occipital Technique, Neurocranial Restructuring (NCR), Cranial

Manipulation

Sound Assisted Soft Tissue mobilization

Chiropractic services directed at controlling progression and/or reducing scoliosis,

including but not limited to the SpineCor brace and CLEAR scoliosis treatment

Repeat imaging to determine the progress of conservative treatment

Thermography

Upledger Technique

Vascular Studies, including, but not limited to, Doppler ultrasound analysis and

plethysmography

VAX-D, Lordex, LTX3000, DRX-9000, DRS (Decompression Reduction Stabilization

System), or other back traction devices charged at a higher rate than mechanical

traction (97012)

Whole Body Vibration (WBV), Vibration Plate, Vibration Therapy

Any lab work for which the office is not CLIA Certified or falls outside of the scope of

practice, including, but not limited to: drug testing, therapeutic drug assays, and

organ or disease oriented panels

Treatment for brachioradial pruritis

Dry Needling

Professional societies have published position statements concluding that diagnostic spinal

ultrasound is investigational for non-operative spinal and paraspinal conditions in adults.

There is insufficient peer-reviewed published scientific evidence that computerized muscle

testing leads to better patient outcomes. There is insufficient evidence to support any

specific therapeutic effect of craniosacral therapy. While there is emerging evidence for the

effectiveness of whole body vibration in treating some medical conditions, the evidence for

whole body vibration as a treatment for LBP remains equivocal.

A 2015 systematic review found that that low level laser therapy is an effective method for

relieving pain in non-specific chronic low back pain patients. However, no significant

treatment effect was identified for disability scores or spinal range of motion outcomes.

Yelden and colleagues (2009), concluded that there is no fundamental difference between

LLLT and placebo LLLT when they are supplementing an exercise program for

rehabilitation of patients with shoulder impingement syndrome. Ay and colleagues (2010),

found no differences between laser and placebo laser treatments on pain severity and

functional capacity in patients with acute and chronic low back pain caused by lumbar disc

herniation. The Blue Cross and Blue Shield Association Technology Evaluation Center

(2010) concluded that LLLT for either carpal tunnel syndrome or for chronic neck pain does

not meet the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC)

criteria. Furthermore, the Work Loss Data Institute's clinical practice guideline on "Carpal

tunnel syndrome" (2011) does not recommend LLLT as a therapeutic option. Kadhim-Saleh


et al (2013) examined the effectiveness of LLLT in reducing acute and chronic neck pain.

The authors concluded that this systematic review provided inconclusive evidence because

of significant between-study heterogeneity and potential risk of bias. They stated that the

benefit seen in the use of LLLT, although statistically significant, does not constitute the

threshold of minimally important clinical difference. Huang et al (2015), found that the best

available current evidence does not support the effectiveness of low level laser therapy as a

therapy for patients with knee osteoarthritis.

There is insufficient evidence to support the clinical value of the Pettibon System.

Thermography has not been shown to provide sufficient reliable characterizing information

about neurologic dysfunction or deficit to accept it as a proven evaluative procedure for the

clinical diagnosis or characterization of: neck or back pain; musculoskeletal pain;

entrapment neuropathy; headache; or transient cerebral ischemia and stroke.

Magellan considers high-density surface electromyography (HD-sEMG), surface scanning

EMG, paraspinal surface EMG, or macro EMG experimental and investigational as a

diagnostic test for evaluating low back pain or other thoracolumbar segmental

abnormalities such as soft tissue injury, intervertebral disc disease, nerve root irritation

and scoliosis, and for all other indications because the reliability and validity of these tests

have not been established. Surface EMG devices are also experimental and investigational

for diagnosis and/or monitoring of nocturnal bruxism and all other indications because the

reliability and validity of these tests have not been demonstrated. The Neurophysiologic

Pain Profile (NPP) and the spine matrix scan (lumbar matrix scan) are considered

experimental and investigational because the reliability and validity of these tests has not

been established.

There is insufficient evidence to conclude that nerve conduction studies are beneficial for

health outcomes in patients with non-specific neck or back pain. Non-invasive automatic or

portable nerve conduction monitoring systems that test only distal motor latencies and

conduction velocities are unproven and not medically necessary for the purpose of

electrodiagnostic testing.

Plethysmography is used to diagnose deep vein thrombosis and arterial occlusive disease.

Plethysmography is used as the sole diagnostic modality for these conditions or as an initial

evaluation to determine the need for venography or arteriography. Body Plethysmography

evaluates total lung capacity and residual volume. Since treatment of cardiovascular and

lung conditions falls outside of the scope of chiropractic, patients should be referred for

testing if these conditions are suspected.

Procedure:

1. Guidelines:

a. If such services are to be provided, the practitioner will inform the member, in

writing, that such services will be the member’s responsibility. None of these

services are to be performed in lieu of an appropriate examination or without

consideration of an appropriate referral.


b. There is limited scientific evidence that the use of experimental, investigational and

unproven services provides an improved or more accurate diagnosis, nor do they

result in an improved clinical outcome.

c. Scientific literature will continue to be reviewed and any significant changes in

published literature will be taken into consideration for modification of this policy.

2. Exclusions/Limitations (not limited to):

Refer to enrollee’s Certificate of Coverage or Summary Plan Description.

3. Removal of a service from the Experimental and Investigations Policy

At least annually, a review of the current literature will be evaluated to determine if

there is additional research in support of any of the services listed under this policy.

This evaluation will include the following criteria:

Safety – Is the potential benefit superior to the potential harm?

Health Outcomes – Is there evidence the service will provide, at minimum, equal

outcomes and, at best, superior outcomes to currently available services?

Patient Management - Will the service improve clinical decision making?

Clinical Performance – Is the reliability as well as predictive value of the service

equal or superior to the current “gold standard” for such services?

Cost-effectiveness – Is the service equal to or lower cost than currently utilized

services for similar diagnosis and treatment?

All criteria will be based on peer-reviewed scientific literature and internationally and

nationally accepted and published guidelines. Peer-reviewed scientific studies must be

published in or accepted for publication by medical journals meeting national requirements

for scientific publication (http://www.icmje.org). The medical literature must meet the

National Institutes of Health Library of Medicine for indexing (http://www.nlm.nih.gov).

Medical journals that publish most of there scientific manuscripts by the editorial staff of a

journal will not be considered for review. If the majority of funding for research is published

by the device manufacturer or organization sponsoring a technique the results will not be

considered for review.

If the service appears to be safe and cost-effective Magellan Healthcare will present these

results to our health plan partners for consideration of coverage and/or payment. Final

authority for such coverage determinations rests with the health plan.


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